Research and Development (R&D) Accreditation

With the recent granting of our first R&D accreditation it is appropriate to provide a brief outline of the R&D accreditation program to date.

 

Over the last few years, we have consistently received enquiries and requests about the possibility of an accreditation program being provided for R&D. These requests generally came from individuals and organisations that had experience of laboratory accreditation. In 2002 we therefore began to explore this possibility in a more structured way. Up until then, some requests (at least the testing side of the R&D activities being undertaken) had been dealt with through our laboratory accreditation program because a significant amount of testing was involved. This was not however entirely satisfactory, as these assessments did not cover the important aspects of the conduct and management of research and development work.

 

In September 2002 a meeting was held with a group of people who had expressed interest in accreditation for R&D activities. This group included representatives from a range of industries, and both public and private sector organisations. Discussions dealt with the need (or not) for accreditation of R&D activities, what are the issues that an accreditation program may be able to address, possible models, potential difficulties and ‘where to from here’.

 

Key issues that participants felt needed to be addressed as part of an audit process included basic good laboratory practice items such as:

 

 

  • record keeping (particularly retention of raw data);
  • equipment calibration and maintenance;
  • use of appropriate statistical techniques;
  • staff training; and
  • records of procedures and methods used, especially where these evolve with ongoing work

Benefits of accreditation were identified as the potential for a reduction in client audits, evidence of appropriate procedures and systems in place for bodies providing funding, and greater confidence in results from organisations carrying out sub-contracted R&D activities. The need to involve providers of funding as part of the development of the program was seen as a priority.

 

Potential difficulties included concern of additional layers of requirements for organisations; who will pay; will it hinder original research; difficulties with the peer assessment concept in terms of confidentiality of research.

 

Possible models discussed included ISO/IEC 17025, GLP, CITAC/Eurachem and ISO 9001. It was recognised a degree of flexibility in applying whichever model was adopted, was needed to allow for the broad range of activities covered by organisations carrying out R&D activities, and to ensure aspects currently reviewed are not unnecessarily duplicated, eg ethics and animal health requirements and journal peer reviews.

 

What has happened since?

 

  • Council R&D Seminar

 

The NATA Council Seminar held in October 2004 looked at the topic of ‘Accreditation of R&D activities’. Speakers included Dr Joseph Patroni (Western Australian Government Representative on NATA’s Council and Manager, Science Capability Development at the Office of Science and Innovation) and Mr Andrew King from TetraQ – ADME. The following issues and points were discussed:

 

  1. accreditation would provide an opportunity to evaluate and manage the technical risks (methods for evaluating and managing the financial risks are already well established);
  2. accreditation would encourage uniformity of practice and standards, within the framework in which the research should be carried out and recorded, eg need to be able to reconstruct the project or study from the records and ability to compare results from one project to another;
  3. accreditation would provide an independent review of the R&D process;
  4. accreditation would provide certainty in the process, even though results/outcomes are unknown.

 

There was also:

 

  1. concern about costs and yet another overhead for organisations carrying out R&D;
  2. a recognition that there was a need to address basic quality issues, eg equipment calibration and issues relating to the management of R&D activities; and
  3. the view that there was a need to talk to organisations that provide funding for R&D work.

 

  • Workshops and papers

 

NATA staff have attended two workshops relating to R & D activities. These were the 7th Australian Research and Development Summit (September 2004); and the NHMRC (National Health and Medical Research Council), ARC (Australian Research Council), AVCC (Australian Vice-Chancellors’ Committee) Workshop, Managing Allegations of Research Misconduct - Does Australia Need a Better System? (August 2005).

 

 

Comment has also been forwarded as part of the public comment process on the Australian Code for Conducting Research 2004 and the Research Quality Framework: Assessing the quality and impact of research in Australia, both of which are aimed at improving the quality of research in Australia.

 

  • First Accreditation for R&D

 

In August 2005 the first accreditation for R&D activities was granted to TetraQ – ADME located at the Royal Brisbane and Women’s Hospital, Queensland. The assessment was conducted using ISO/IEC 17025 and the CITAC/Eurachem document Quality Assurance for R&D and Non-Routine Analysis available from the CITAC website. The scope of accreditation includes “management and conduct of research into pharmaceutical /biotechnology agents using appropriately validated human and mammalian animal models applicable to adsorption/distribution/metabolism/elimination studies and involving the determination of analytes in biological matrices.” The full scope of accreditation and contact details for TetraQ – ADME are available from the directory on our web site.

 

Where to from here?

We are continuing to receive enquiries from organisations that are interested in our R&D accreditation program. We are dealing with these on an individual basis in terms of their needs and expectations of accreditation, and just what we can deliver.

 

The subject of R&D accreditation has also been raised in ILAC and APLAC and there is great interest from other accreditation bodies in NATA’s experience.

 

If you are interested in information on the R&D accreditation program, please contact jane.king@nata.asn.au